JOURNAL ONKOLOGIE – STUDIE

Comparison Between Endovascular and Bronchoscopic Tumor Marker Insertion for Real-time Stereotactic-guided Radiotherapy in Lung Cancer

Studien-Informationen Einschlusskriterien Studien-Rationale Studien-Arme Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT04684186

Studienbeginn:
Oktober 2016

Letztes Update:
12.01.2021

Wirkstoff:
-

Indikation (Clinical Trials):
Lung Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Centre Hospitalier Universitaire Vaudois

Collaborator:
-

Kontakt

Rafael DURAN, MD
Kontakt:
Phone: +41213144444
E-Mail: rafael.duran@chuv.ch» Kontaktdaten anzeigen

Studienlocations (1 von 1)

Centre Hospitalier Universitaire vaudois - Department of Radiology and Interventional Radiology
1011 Lausanne
SwitzerlandRekrutierend» Google-Maps
Ansprechpartner:
Rafael DURAN
Phone: +41213144444
E-Mail: rafael.duran@chuv.ch» Ansprechpartner anzeigen

Studien-Informationen

Brief Summary:

The role of radiotherapy is well established in the management of early stage lung cancer or

as part of a multidisciplinary approach of locally advanced lung cancer (1).

Recent advances in Cyberknife© technology, which is a robotic system of stereotactic

irradiation including localisation and real time lesion-tracking, has led to an increase in

accuracy and potentially in efficiency of the irradiation of tumor field (2)(3). According to

several studies, promising results in local control and survival rates have been achieved in

patients suffering from primary lung cancer or peripheral lung metastasis treated with

Cyberknife© (4)(5)(6)(7)(8).

Fiducial markers are implanted in or near a tumor in a configuration defining a COM (center

of mass) guiding the Cyberknife for tumor localization.

Tumor movement is then synchronized to respiratory cycle motion during treatment which

reduces toxicity of non target lung tissue irradiation. Change in marker positioning leads to

COM alterations, thus limiting detection by the tracking system.

Percutaneous (9)(10)(11) (12), endovascular (12)(13) fiducial implantation or by means of

bronchoscopic devices (14)(15)(16)(17)(18) are three techniques that have been validated in

previous studies as feasible and safe procedures, providing accurate tracking.

Few studies are currently available in the litterature comparing these modalities (19)(20).

The percutaneous implantation technique will not be considered for this study because this

technique is associated with a high risk of pneumothorax (9).

Both the endobronchial and endovascular technique have been described in the literature with

equivalent success rate (87-90%) in intention to treat (21)(22).

One of the endpoints of this study is to verify that these results are reproducible in our

institution where both techniques are currently available and to investigate other secondary

endpoints such as fiducial marker migration after placement, complications rates and

procedure time.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Lung cancer (primary or secondary, any histological type)

- Early stage lung cancer: patients diagnosed with stage I for which operation is

contra-indicated, for example because of cardiac or pulmonary comorbidities.

- Locally advanced lung cancer stages II - IIIB

- Metastatic lung cancer stage IV (palliative care)

- 18 y ≤ age ≤ 85 y

Exclusion Criteria:

- age <18y

- incapacity of judgment

- Absence of a signed consent form

Studien-Rationale

Primary outcome:

1. Cyberknife© tracking (Time Frame - Before Cyberknife):
Tumor tracking assessment by Cyberknife© after bronchoscopic and endovascular fiducial marker implantation

Secondary outcome:

1. Fiducial implantation evaluation by operator (Time Frame - Immediately post-implantation):
Assessment of technical feasibility of implantation of at least three fiducial markers around the lung tumor in both techniques

2. Fiducial marker migration (Time Frame - Immediately post-implantation and before Cyberknife):
Secondary fiducial migration rate assessment in both techniques

3. Procedure time (Time Frame - Immediately after the procedure):
Procedure time required for the implantation of three markers around the lung tumor in both techniques

4. Complication rate (Time Frame - within 30 days of fiducial marker placement):
Complication rate (AE/SEA) within 30 days of fiducial marker placement in both techniques

Studien-Arme

Endovascular fiducial marker insertion
Fiducial markers are inserted and released near the tumor through femoral puncture. A catheter is led through the venous system to the right heart and from there through the heart into the pulmonary arteries.
Bronchoscopic fiducial marker insertion
Fiducial markers are inserted and released near the tumor into the bronchi using an endoscopic route

Geprüfte Regime

Endovascular fiducial marker insertion:
Fiducial markers will be inserted using an endovascular route
Bronchoscopic fiducial marker insertion:
Fiducial markers will be inserted using an endoscopic route

Quelle: ClinicalTrials.gov